FDA OKs 3Shape’s Dx Software for Dental Diagnosis

3Shape has gained U.S. Food and Drug Administration (FDA) clearance for its Dx software.

The software can now be commercially available in the U.S., for use by qualified dental professionals in dental clinics. It aids in diagnosis of key oral health conditions and assessment of changes in teeth and gingiva in adults.

The clearance applies to both versions of the company’s software: Dx Plus and Dx Standard. Dx Plus is an artificial intelligence (AI)-assisted software that helps with detection of surface and proximal caries, plaque, tooth wear, and gingival recession. It’s exclusively compatible with 3Shape TRIOS 6 scans.

Dx Standard manually tracks and quantifies changes to patients’ dentition to help dentists engage patients. It’s compatible with all 3Shape TRIOS models except for TRIOS Core.

Using Dx, dentists can visualize key oral health conditions with their patients onscreen and monitor them over time. Dx Plus visualizations transform clinical findings into clear, intuitive visuals to help patients better understand their diagnosis, build trust with their clinician, and feel more confident in recommended treatment plans.

“I’m excited that we can now bring this transformative dental solution to doctors and patients across the United States,” said 3Shape CEO Jacob Paulsen. “Receiving FDA 510(k) clearance for Dx underscores our commitment to responsible innovation and to delivering digital solutions that meet the highest clinical and regulatory standards. With Dx software, dental professionals gain a powerful new way to communicate more clearly with patients about their oral health and treatment needs.”